A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Meeting 1 of the following criteria:

- History of breast cancer (currently without malignant disease)

- No history of breast cancer, but patient wishes to avoid estrogen due to a
perceived increased risk of breast cancer

- Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of
sufficient severity to make the patient desire therapeutic intervention)

- Presence of hot flashes for ≥ 1 month prior to study entry

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy ≥ 6 months

- Able to complete questionnaire(s) by themselves or with assistance

- Women of childbearing potential not eligible (per the judgment of the attending
clinician)

- Serum creatinine ≤ 1.5 times upper limit of normal

PRIOR CONCURRENT THERAPY:

- No prior gabapentin or pregabalin

- More than 4 weeks since prior and no concurrent antineoplastic chemotherapy,
androgens, estrogens, or progestational agents

- Vaginal estrogen is allowed if used for the past month and not planned to be
discontinued

- Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab [Herceptin®])
allowed in patients with no evidence of disease

- Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at
least 4 weeks allowed provided the medication will not be stopped during the study
period

- No concurrent or planned use of other agents for hot flashes except for any of the
following:

- Stable dose of vitamin E is allowed as long as agent was started > 30 days prior
to study initiation and is to be continued throughout the study period

- Soy is allowed, if it is planned to be continued at the same dose during the
study period

- Stable dose of antidepressants is allowed as long as it was started > 30 days
prior to study initiation and is to be continued at a stable dose throughout the
study period